Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation

NCT03533010 | Completed

• 1 other identifier: CalE_Protocol_V04
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily \[500mg Ca + 800 IU Vit-D\] can improve bone health and prevent curve progression in AIS. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology(HR-pQCT) to assess bone health will also be evaluated.

Conditions

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Health; Vitamin D

Keywords

Adolescent Idiopathic Scoliosis; Bone Health; Treatment; Vitamin D; Calcium

Outcome Measures

Primary Outcomes (2)

• Curve progression (Cobb)

  Percentage of patients with increase in Cobb angle ≥ 6 degrees

  3 years

• Curve progression (Bracing)

  Percentage of patients who require bracing

  3 years

Secondary Outcomes (2)

• Bone health (BMD)

  3 years

• Bone health (bone quality)

  3 years

Study Arms (2)

Ca500mg + VitD800IU

ACTIVE COMPARATOR

Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3

Dietary Supplement: Ca500mg; Dietary Supplement: VitD800IU

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Other: Placebo

Interventions

Ca500mg DIETARY_SUPPLEMENT

subjects receive a daily dose of 500mg elemental calcium

Also known as: Calcium 500mg

Ca500mg + VitD800IU

VitD800IU DIETARY_SUPPLEMENT

subjects receive a daily dose of 800IU VitD3

Also known as: Vitamin D3 800IU

Ca500mg + VitD800IU

Placebo OTHER

subjects receive placebo tablet

Placebo

Eligibility Criteria

• Age: 10 Years - 14 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• girls with diagnosis of AIS confirmed after detailed clinical and radiological assessment and
• between 10 to 14 years old and
• Risser between 0 to 2 and
• pre-menarche or \< 1 year post-menarche and
• Cobb angle between 10° to 20 ° and
• no prior bracing or other treatment for scoliosis and
• no prior treatment for bone health

You may not qualify if:

• scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia or
• patients with known endocrine and connective tissue abnormalities, or
• patients with eating disorders or gastrointestinal malabsorption disorders or any disorders that are known to affect calcium or bone metabolism or
• prior treatment for bone health before being recruited into the study or
• patient currently taking medication that affects bone metabolism eg steroid or
• patient with contra-indications for calcium and Vit-D supplementation:
• history of hypersensitivity to the active or placebo tablets
• history of renal diseases and renal calculi (nephrolithiasis)
• diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
• hypervitaminosis D

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Scoliosis; Spinal Curvatures; Spinal Diseases

Interventions

Calcium; Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Tsz Ping Lam

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Clinical)

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 22, 2018
• Study Start: June 1, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)